benzonatate

Generic: benzonatate

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benzonatate
Generic Name benzonatate
Labeler strides pharma science limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

benzonatate 100 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-712
Product ID 64380-712_21343425-d42f-4a46-ba47-30cedc9fe876
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091133
Listing Expiration 2026-12-31
Marketing Start 2016-12-10

Pharmacologic Class

Established (EPC)
non-narcotic antitussive [epc]
Physiologic Effect
decreased tracheobronchial stretch receptor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380712
Hyphenated Format 64380-712

Supplemental Identifiers

RxCUI
197397 283417
UPC
0364380712077 0364380712060 0364380713074
UNII
5P4DHS6ENR
NUI
N0000009010 N0000175796

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benzonatate (source: ndc)
Generic Name benzonatate (source: ndc)
Application Number ANDA091133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 CONTAINER (64380-712-06)
  • 500 CAPSULE in 1 BOTTLE (64380-712-07)
source: ndc

Packages (2)

64380-712-06 100 CAPSULE in 1 CONTAINER (64380-712-06) 64380-712-07 500 CAPSULE in 1 BOTTLE (64380-712-07)

Ingredients (1)

benzonatate (100 mg/1)

Linked Drug Pages (1)

Benzonatate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21343425-d42f-4a46-ba47-30cedc9fe876", "openfda": {"nui": ["N0000009010", "N0000175796"], "upc": ["0364380712077", "0364380712060", "0364380713074"], "unii": ["5P4DHS6ENR"], "rxcui": ["197397", "283417"], "spl_set_id": ["89f5d18e-5ef4-42a3-bc6f-abf4f308462b"], "pharm_class_pe": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]"], "pharm_class_epc": ["Non-narcotic Antitussive [EPC]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 CONTAINER (64380-712-06)", "package_ndc": "64380-712-06", "marketing_start_date": "20161210"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (64380-712-07)", "package_ndc": "64380-712-07", "marketing_start_date": "20161213"}], "brand_name": "Benzonatate", "product_id": "64380-712_21343425-d42f-4a46-ba47-30cedc9fe876", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Tracheobronchial Stretch Receptor Activity [PE]", "Non-narcotic Antitussive [EPC]"], "product_ndc": "64380-712", "generic_name": "Benzonatate", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benzonatate", "active_ingredients": [{"name": "BENZONATATE", "strength": "100 mg/1"}], "application_number": "ANDA091133", "marketing_category": "ANDA", "marketing_start_date": "20161210", "listing_expiration_date": "20261231"}